A POPULATION-BASED cohort study finds that asthma patients treated with dupilumab may face an increased risk of developing lymphoma, particularly T and natural killer (NK) cell subtypes, compared to those treated with standard combination inhalers. Despite this elevated risk, dupilumab was also associated with a significant reduction in all-cause mortality.
The study included 14,936 patients with asthma who began treatment with dupilumab between 2018 and 2024, and compared them to 734,126 patients receiving standard ICS/LABA therapy. Researchers applied propensity score matching to control for baseline differences across groups, ensuring a robust comparative analysis.
Patients treated with dupilumab experienced a higher incidence of lymphoma (54 cases) than those in the ICS/LABA cohort (43 cases), with a hazard ratio (HR) of 1.79 (95% CI, 1.19–2.71). The disparity was most notable for T and NK cell lymphomas, with a hazard ratio of 4.58 (95% CI, 1.82–11.53). Importantly, the incidence of other malignancies did not differ significantly between the two treatment groups.
Despite the concerning lymphoma signal, the analysis revealed a statistically significant reduction in all-cause mortality among dupilumab users. The dupilumab group experienced 328 deaths, compared to 793 in the matched ICS/LABA cohort (HR=0.65, 95% CI, 0.57–0.74), suggesting a potential survival benefit associated with the biologic.
The authors emphasize the need for long-term pharmacovigilance and mechanistic studies to understand the immunological factors contributing to the observed lymphoma risk. These findings underscore the complexity of evaluating biologic therapies, where benefits in disease control and survival must be carefully weighed against emerging safety signals.
Clinicians prescribing dupilumab for asthma should remain vigilant for lymphoproliferative symptoms and consider individual risk factors when selecting treatment strategies. While the mortality benefits are encouraging, ongoing research will be essential to refine risk stratification and guide patient counseling.
Reference:
Ma KS et al. Dupilumab and lymphoma risk among patients with asthma: a population-based cohort study. Eur Respir J. 2025 Jun 19:2500139. doi: 10.1183/13993003.00139-2025. [Online ahead of print]
